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Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Wiley Rein LLP

[Webinar] EPA Risk Evaluations Under TSCA: Three Things Companies Should Know About General Population Risk Evaluation - November...

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Section 6 of the Toxic Substances Control Act (TSCA) requires an assessment of unreasonable risk to “potentially exposed or susceptible subpopulations” (PESS) in high-priority substance risk evaluations. Wiley is partnering...more

Wiley Rein LLP

[Webinar] EPA Risk Evaluations Under TSCA: What’s at Stake and How to Prepare - May 16th, 12:00 pm - 1:00 pm EDT

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On May 3, 2024, the U.S. Environmental Protection Agency’s (EPA) final rule on procedures for chemical risk evaluation under the Toxic Substances Control Act (TSCA) was published in the Federal Register. In the words of EPA’s...more

Downey Brand LLP

EPA Adds Extensive New Amendments to its Risk Management Program in Final Rule

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On March 11, 2014, the Environmental Protection Agency (EPA) published in the Federal Register amendments to the Risk Management Program (RMP) rule (Final Rule). Going into effect on May 10, 2024, EPA’s Final Rule, named the...more

Goldberg Segalla

EPA’s Final EtO Rule Finally Finalized

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The Environmental Protection Agency on March 14 announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) applicable to 90 large commercial sterilization facilities that use ethylene...more

Bergeson & Campbell, P.C.

EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses

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On March 15, 2019, the U.S. Environmental Protection Agency (EPA) published a signed final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and...more

Jones Day

An Assessment and Comparison of New TSCA and REACH

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Passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, or "New Toxic Substances Control Act," introduces a number of changes to regulations for the collection and assessment of information concerning...more

Williams Mullen

Environmental Notes - August 2016

Williams Mullen on

Time to Pay More: EPA Increases Maximum Civil Penalties - Remember the days when the maximum civil penalty EPA could assess for a violation of environmental law was $25,000 per day? Those days disappeared 26 years ago...more

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